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. 2019 Oct 21;2:14. Originally published 2019 Jul 19. [Version 2] doi: 10.12688/hrbopenres.12924.2

Table 2. Number and percentage of studies reporting external validity elements 1.

External validity dimension Definition Studies
reporting
Yes/Total 2 %
Reach and representativeness of individuals
Target population for generalizability Is the intended target population acknowledged/stated (at the individual level)
for which the findings intend to be generalised to?
38/39 97
Method to recruit target population Was information provided about how the target population was recruited/
reached (e.g., radio, newspaper, TV, school meeting)?
30/39 77
Inclusion or exclusion criteria Were individual inclusion and exclusion criteria stated? 38/39 97
Enrolment rate Is the enrolment rate or data needed to calculate the enrolment rate among
individuals reported? Proportion of people who are eligible for participation who
actually enrol in the study
26/39 67
Recruitment rate Is the recruitment rate or data needed to calculate the recruitment rate among
individuals reported? Proportion of potential participants (those invited or
expressing interest) who actually enrol in the study
26/39 67
Representativeness of individuals Are there comparisons between individuals who participated versus either (1)
those who declined to participate or (2) target population?
10/39 26
Participant characteristics Are all of the following reported:
•Gender
•Age
•Any socioeconomic indicators (education, employment status, or income)
•Participation by racial or ethnic minority groups
21/39 54
Reach and representativeness of settings
Target setting Is the target setting for intervention delivery stated (such as workplace, general
practice, outpatient facilities, churches, etc.)?
35/38 92
Method to recruit setting Is information provided about how the site(s) within a given setting were
recruited/reached to participate in delivering the intervention?
4/28 14
Inclusion or exclusion criteria Were inclusion and exclusion criteria for selection of sites within a given
setting stated? In the case of single sites, were the characteristics of the site
described?
6/28 21
Participation rate Is the participation level or data need to calculate the participation level among
eligible sites reported (only applies to studies with more than one site)?
1/19 5
Representativeness of setting(s) Are there comparisons between site(s) participating in the intervention and 1)
those that decline to participate or 2) the target setting?
1/28 4
Implementation and adaptation
Intervention characteristics Were the intervention components described? 38/39 97
Intervention adaptation Is information reported about how the study intervention is similar or different to
original efficacy studies?
Note: Only applicable to studies where an intervention is adapted from a
previous trial
0/5 0
Time to deliver intervention
described
Is the number and length of sessions or time required to deliver the intervention
described?
24/37 65
Intervention delivery and exposure Was the extent to which individuals were exposed to the intervention
described? (e.g. proportion of planned intervention sessions actually attended
(dose); content delivered as specified; provider adherence to intervention plan)
24/37 65
Delivery agents: characteristics and
training
Is information provided on who delivered the intervention, such as the type of
professional, or the amount of experience, skill or training required to deliver the
intervention?
37/39 95
Methods to recruit delivery agents Is information provided about how the delivery agents were identified/selected? 3/36 8
Delivery agents’ participation Is the participation level amongst delivery agents reported (% of delivery
agents agreeing to participate)?
4/35 11
Fidelity assessment: treatment
receipt
Is information reported about whether the program was received as intended?
(e.g. degree to which the participants understood the intervention and/or ability
to perform the intervention skills)
4/39 10
Mechanisms for intervention effects Was retrospective analysis conducted to identify the mediating variables
through which the intervention achieved its effect?
2/39 5
Outcomes for decision making
Outcomes that can be compared to
standards
Are outcomes (at least one) reported in a way that can be compared to either
clinical targets or public health goals?
36/39 92
Adverse consequences Does the article report whether they examined the occurrence of unintended
consequences?
18/39 46
Effect moderators by participant
characteristics
Are there any analyses of moderator effects by subgroups of participants 10/39 26
Effect moderator by delivery agent/
setting
Are there any analyses of moderator effects by delivery agents or settings 0/37 0
Dose response effect of intervention
(sensitivity)
Are there sensitivity analyses to assess dose-response effects of the
intervention?
1/39 3
Total costs of intervention Are total costs of the intervention presented? 6/39 15
Cost of intervention components If costs are presented, were the costs itemized by intervention components
(e.g., personnel, equipment)?
4/6 67
Cost effectiveness If costs are presented, was there any analysis done to assess cost-
effectiveness or cost-benefit of the program or policy?
3/6 50
Maintenance / institutionalisation
Long term effects (at least 12
months) 3
Are data reported on longer term effects on health-related outcomes, at least 12
months following program implementation, or environmental or policy change?
19/39 49
Institutionalization: sustainability /
plans for sustainability
Are data reported on the sustainability (or reinvention or evolution) or plans for
sustainability of the intervention?
4/39 10
Attrition Are data reported on the number of individuals dropping out and/or lost to
follow up
38/39 97
Differential attrition (by condition or
population sub-group)
Are data on attrition by condition or population sub-group reported? 35/39 90
Representativeness of completers/
dropouts
Did the study report statistically significant differences in those that dropped out
of treatment and those that finished?
19/38 50
Acceptability of the intervention by
stakeholders
Was information provided about acceptability of the intervention by
stakeholders?
14/39 36

Notes:

1Laws et al. (adapted from Green et al.)

2Total = the no. of overall studies (n=39) minus the no. of studies reporting not applicable to the relevant element

3In RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance), long-term results of intervention are defined as a minimum of six months following the last contact; long-term is defined as a minimum of 12 months by Laws et al.